The ESAOTE sales and service centre network is world-wide. For the address of
your local distributor, contact your nearest ESAOTE subsidiary. In case of difficulty a complete list of all distributors and subsidiaries is provided on our internet site:
http://www.esaote.com
Article-No.: 9740440041 Rev.: a
Issue date: 23.12.03
Ref.S.: 2.510532
The ESAOTE sales and service centrenetwork is world-wide. For the address ofyourlocal distributor, contact your nearest ESAOTE subsidiary. In case of difficul-ty a complete list of all distributors and subsidiaries is provided onour internet site:http://www.esaote.com
V This device must only be used by qualified doctors or trained medical personnel.
V The numerical and graphical results and any interpretation given must be exami-
ned with respect to the overall clinical condition of the patient and the general recorded data quality.
V The indications given by this equipment are not a substitute for regular checking
of vital functions.
V Specify the competencies of the personnel for operation and repair.
V Ensure that personnel have read and understood these operating instructions. In
particular this chapter “safety notes" must be read and understood.
V Have damaged or missing components replaced immediately.
V The operator is responsible for compliance with all applicable accident prevention
regulations and safety regulations.
Safety notes1
1.2Intended Use
V The P8000 is a 3/12-channel, ECG device used for the recording, analysis and
evaluation of ECG Recordings. Recordings made with the P8000 can be used as
a diagnostic aid for heart function and heart conditions. The P8000 is designed
for indoor use and can be used for all patients of both sexes, all races, and all
ages.
V There is no danger for patients with pacemaker.
V Only operate the device in accordance with the specified technical data.
V The system is not designed for sterile use nor is it designed for outdoor use.
V Do not use this unit in areas where there is any danger of explosion or in the pre-
sence of flammable gases such as anaesthetic agents.
VThis unit is CF classified and defibrillation protected only when the original
patient cable is used. However, as a safety precaution when possible, remove
electrodes before defibrillation.
V This product is not designed for internal use.This product is not designed for di-
rect cardiac application.
1.3Organisational Measures
V Before using the unit, ensure that an introduction regarding the unit functions and
the safety precautions has been provided by a medical product representative.
V Keep these operating instructions in an accessible place for reference when re-
quired. Make sure that they are always complete and legible.
V Observe the operating instructions and maintenance instructions.
V These operating instructions do not override any statutory or local regulations, or
Art.-no.: 9740440041 Rev.: a
procedures for the prevention of accidents and environmental protection.
Page 3
1Safety notes
1.4Safety-conscious Operation
1.4Safety-conscious Operation
1.5Safety Facilities
V Make sure that the staff has read and understood the operating instructions - par-
ticularly the "Safety Notes" chapter.
V Do not touch the unit casing during defibrillation.
V It must be ensured that neither the patient nor the electrodes (including the neu-
tral electrode) come into contact with other conducting objects (even if these are
earthed).
V Immediately report any changes that impair safety (including operating beha-
viour) to the person responsible.
V Do not place any liquids on the unit. If liquid should be spilled over the device,
immediately disconnect the device from the mains and wipe it. The device must
be serviced before reusing.
V Operating the device without the correctly rated fuse, or with defective cables,
constitutes a danger to life. Therefore:
– Do not operate the unit if the earth connection is suspect or if the mains lead is
damaged or suspected of being damaged.
– Damaged cable connections and connectors must be replaced
immediately.
– The electrical safety devices, such as fuses, must not be altered.
– Ruptured fuses must only be replaced with the same type and rating as the ori-
ginal.
Page 4
Art.-no.: 9740440041 Rev.: a
Safety notes1
User GuideOperation with other Devices1.6
1.6Operation with other Devices
V Use only accessories and other parts recommended or supplied by ESAOTE.
Use of other than recommended or supplied parts may result in injury, inaccurate
information and/or damage to the unit.
V Ancillary equipment connected to the analogue and/or digital interfaces must be
certified according to the respective IEC standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore
all configurations shall comply with the valid version of the system standard IEC/
EN 60601-1-1. Everybody who connects additional equipment to the signal input
part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service department or your local representative.
– EC/EN 60601-1-1 states that the patient must remain at least 1.5 meters clear
of the unit. If this is not possible, a safety isolating transformer must be installed.
V Any other equipment used with the patient must use the same common earth as
the P8000.
V Precautions must be observed when using high frequency devices. Use the spe-
cial high frequency ESAOTE patient cable to avoid possible signal interference
during ECG acquisition.
V There is no danger when using the ECG unit simultaneously with electrical stimu-
lation equipment. However, the stimulation units should only be used at a sufficient distance from the electrodes. If in doubt, the patient should be disconnected
from the monitor.
V If the patient cable should become defective after defibrillation, an electrode be-
comes displaced, or an electrode resistance is too high, a lead-off indication is
displayed in the upper right part of the screen and an acoustic alarm given.
1.7Maintenance
V Danger of electric shock! Do not open the device.No serviceable parts inside.
Refer servicing to qualified personnel only.
V Before cleaning and to isolate the mains power supply, switch the unit off and di-
sconnect it from the mains by removing the plug.
V Do not use high temperature sterilisation processes
(such as autoclaving). Do not use E-beam or gamma radiation sterilisation.
V Do not use solvent or abrasive cleaners on either the unit or cable assemblies.
V Do not, under any circumstances, immerse the unit or cable assemblies in liquid.
Art.-no.: 9740440041 Rev.: a
Page 5
1Safety notes
1.8Safety Symbols and Pictograms
1.8Safety Symbols and Pictograms
The safety level is classified according ANSI Z535.4. The following overview shows
the used safety symbols and pictograms used in this manual.
For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation, which could lead to heavy bodily injury or to death.
For a possibly dangerous situation which could lead to personal injury. This symbol is
also used to indicate possible damage to property.
For general safety notes as listed in this chapter.
Used for electrical dangers, warnings and other notes in regarding operation with
electricity.
Note For possibly dangerous situations, which could lead to damages to property or
system failure.
Important or helpful user information
Reference to other guidelines
Potential equalization
CF symbol. This unit is classified safe for internal and external use. However, It is only
defibrillation protected when used with the original ESAOTE patient cable!
Page 6
The unit/component can be recycled.
Art.-no.: 9740440041 Rev.: a
Notified body of the CE certification (TÜV P.S.)
User GuideTerms of Warranty1.9
1.9Terms of Warranty
The ESAOTE P8000 is warranted against defects in material and manufacture for the
duration of one year (as from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles
free replacement of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorized or unqualified persons attempt to make repairs.
In case of a defect, send the apparatus to your dealer or directly to the manufacturer.
The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if:
• assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by him, and
• the ESAOTE P8000 and approved attached equipment is used in accordance with
the manufacturers instructions.
There are no Express or implied warranties which extend beyond the warranties hereinabove set forth. ESAOTE makes no warranty of merchantability or fitness for a
particulare purpose with respect to the product or parts therefof.
Safety notes1
This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part 15 of the FCC (Federal Communications Commission) Rules and the radio interference regulations of the Canadian Department of
Communications. These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with this instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area
is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.
Art.-no.: 9740440041 Rev.: a
Page 7
2Introduction
2.1Features
2Introduction
2.1Features
The ESAOTE P8000 is a 3/12-channel ECG unit designed to record, display, and
analyse resting ECGs. The unit has been extensively researched to give an ergonomic, clear interface that‘s easy to use without compromising functionality. The P8000
has the following features:
2.1.1Standard Features
• Alphanumeric keypad and dedicated soft key interface for easy, user friendly
operation.
• Integral thermal quality printer with various user defined print format
options.
• Measurements and average cycles with automatic and manual printout of the recording.
2.1.2Optional Features
• External printer
• ECG Interpretation
• Memory for up to 40 recordings
• Thrombolysis
Page 8
Art.-no.: 9740440041 Rev.: a
User GuideOperating Philosophy Overview2.2
2.2Operating Philosophy Overview
There are broadly four types of data display as follows:
Introduction2
Data Acquisition and ECG
Recording Screen
In this screen the real-time ECG is displayed. From this screen a continuous printout
can be initiated and/or an auto recording can be made. In auto mode 10 seconds of
ECG data is analysed and averaged and the results given on a printout. The format
and data of an auto mode printout is independent of the screen display and is defined
in the setup screens. (See paragraph 5.2 page 32).
An auto mode recording can also be stored in the memory for later print or
transmission.
Memory ScreenIn this screen stored recordings can be accessed, printed and transmitted.
Patient Data ScreenPatient data entry via the keypad.
Data Entry and Setup In these screens all system settings are made.
2.2.1Initiating Functions or Tasks
Most functions and tasks are initiated by the 5 softkeys (1) situated immediately below
the LCD. The function of the softkeys varies according to the screen displayed and is
displayed on the LCD immediately above the key itself.
During data acquisition, further dedicated function keys are provided to make an auto
mode recording (START) and to stop a manual printout (STOP). The top line of the
alphanumeric keypad, additionally enables direct settings of lead group, trace speed
and sensitivity, filter on/off and other functions, for both the real-time display and
(manual) printout.
LEAD
TEST
MANUAL
PRINT
MENU
1
Fig. 2.1Start-up screen
Art.-no.: 9740440041 Rev.: a
Page 9
2Introduction
2.2Operating Philosophy Overview
2.2.2Main Components of the P8000
(1) LCD Display
(2) Softkey control
(3) Keypad and dedicated function keys
(4) Printer
1
2
3
2.2.3Back Panel
V All externally connected hardware must be approved by ESAOTE. Connection of
any hardware not approved by ESAOTE is at the owner‘s risk. The unit warranty
may also be invalid. See also safety note paragraph 1.6.
(1) Patient cable connector
(2) LPT connector for the connection of an external printer
(3) RS-232 for connection of a modem or a PC for export of stored recordings
(4) Mains connector (with fuse above)
(5) Potential equalisation stud
1
4
2
3
Art.-no.: 9740440041 Rev.: a
Page 10
4
5
User GuideKeypad2.3
2.3Keypad
Introduction2
LEAD
TEST
MANUAL
PRINT
MENU
2
3
1
(1) Softkeys - the function of these keys changes depending on the screen di-
splayed. The function of these keys is shown on the screen above the keys. If
nothing is written above a softkey, it has no function for the current screen.
(2) Auto Mode recording (in Auto mode 1). Press the SHIFT followed by the START
key (2) for auto mode 2.
(3) STOP printout
Art.-no.: 9740440041 Rev.: a
Page 11
2Introduction
2.3Keypad
4 5 6 7 8 9 10 11 12 13
17
16
1415
(4) The top figures on the number keys ‘1‘and ‘2‘(designated < and >), change the
lead group displayed on the screen, forward and backward resp.
(5) Auto sensitivity key - automatically sets the ECG printout sensitivity (in AUTO
mode only) to the best setting for the signal strength (5mm/mV or 10mm/mV)
(6) The top figures on the number keys designated 5, 10, and 20 set the sensitivity
of the ECG both on the screen and on the (manual) printout. The sensitivity is
5, 10 or 20 mm / mV.
(7) The top figures on the number keys designated 5/10, 25, and 50 set the speed
of the ECG both on the screen and on the (manual) printout. The speed on the
screen can only be set to 25 or 50 mm/s. The speed of the manual printout can
be 5, 10, 25 or 50 mm/s. The 5 and 10 mm/s settings are both on the same key
which toggles the two speeds.
(8) Inserts a 1mV reference marker on the screen and printout. Recentres the trace.
(9) Toggles the QRS beeper ON/ OFF
(10) Myogram filter ON / OFF. The cutoff frequency can be user defined in ‘Setup‘.
(11) Patient data key. Press this key to enter a new patient or modify the data for the
current one.
(12) Delete last typed character.
Page 12
The patient data screen, or the ECG screen is the first screen displayed on initial
switch on. This is set for user preference in the SYSTEM SETTINGS/UNIT (see
page 39).
(13) ON / OFF Key
(14) Mains Indicator - lit when mains connected.
(15) Press the function key (16) and the UP/DOWN arrows to adjust screen contrast.
When entering patient data use the LEFT/RIGHT arrow keys to move the cursor
in the data field. Use the UP/DOWN arrow keys to go up/down to the next data
entry
(16) Shift key to select capital letters.
(17) Function Key. When pressed before another key, initiates the second function
of that key.
For example, second letters on the keypad -, é, è, ç, Ø, ›, @ etc., are entered
by holding the function key before pressing the letter key.
Art.-no.: 9740440041 Rev.: a
User GuideLCD Screen2.4
2.4LCD Screen
The display will vary according to the current task being carried out. In all screens
however, the top and bottom lines always display the same information: the top line
displays system information, and the bottom line always gives the softkey options.
The following is an example of a typical resting ECG screen.
Introduction2
1
~
4
5
2
6
7
8
9
10
LEAD
3
TEST
MANUAL
PRINT
MENU
Items 1, 2 and 3 are in the same position for all screens.
(1) Top line - time, date, patient name, and current power source - mains (~), or bat-
tery (). When battery capacity is limited the battery symbol flashes.
(2) Data acquisition area or data entry area.
(3) Softkey designation. Pressing the key below the text carries out the function in-
dicated. The options available will change according to the screen displayed.
Items 4 to 10 are specific for ECG acquisition only:
(4) Current Heart Rate (averaged over 4 beats and refreshed every 2 seconds).
The HR is also given on a manual printout. Note that with an auto mode printout
the HR is averaged over the full 10 seconds of the recording.
(5) Electrode connections - when an electrode indication flashes (an audible alarm
is also given), it indicates that the electrode resistance is too high. The electro-
de(s) must be reapplied.
(6) Sensitivity 5, 10 or 20 mm/mV. Change the sensitivity with the keys 3 (auto), 4,
5 and 6. An ‘A‘ in this box indicates that automatic sensitivity is selected (auto
mode printout only).
(7) Speed 25 or 50 mm/s. Change the speed with the keys 8 and 9.
(8) Lead indication (leads currently displayed on the screen). Change the lead
group with the < and > keys on the keypad.
1
Myogram Filter indication - ‘Filter ON’ or ‘Filter OFF’. The filter is applied with
(9)
the filter key.
Art.-no.: 9740440041 Rev.: a
(10) Area for system messages or instructions.
1.The frequency of the filter cutoff is defined on page 35 menu Filters.
Page 13
3Operation
3.1Start-up and Initial Preparation
3Operation
3.1Start-up and Initial Preparation
3.1.1Connecting P8000
V Danger of electrical shock. Do not operate the unit if the earth connection is sus-
pect or if the mains lead is damaged or suspected of being
damaged.
(1) Potential equalisation
(2) Mains connection (115 or 230 V)
(3) RS-232 (see safety note paragraph 1.6)
(4) Printer (see safety note paragraph 1.6)
Fig. 3.1P8000 back panel
1. Check Voltage setting (2) 115 or 230 V. Refer to chapter 6.4 for the mains voltage.
2. Connect the power cable at the rear of the unit. The mains indicator lamp (6) is
5
6
7
always lit when the unit is connected to the mains supply. If the unit is switched
on, the relevant symbol is displayed on the LCD (7). Leave the P8000 connected
to the mains for 7 hours to fully charge the battery.
3. Connect the potential equalisation cable and all other necessary cables at the rear of the P8000.
4. Press the on/off button (5). The patient data or the ECG acquisition screen is displayed (see paragraph 5.3.1).
5. Check the settings according to chapters 5.
6. Connect the patient cable on the right side panel.
Art.-no.: 9740440041 Rev.: a
Page 14
User GuideStart-up and Initial Preparation3.1
3.1.2Battery Operation
Important
The unit can either be operated from the mains supply or from the built-in rechargeable battery. The power source is indicated on the top line of the LCD. The internal bat-
1
tery provides power for up to 3 hours.
• When the unit is running on battery power a battery symbol (1) is displayed.
• When working from battery power, the unit is automatically switched off after 5 minutes (30 seconds if battery capacity is limited) if no key is pressed.
• for Battery recharging refer to chapter 6.3.
• The unit can remain connected to the mains supply without damage to either the
battery or the unit.
Operation3
3.1.3Switching ON and OFF
« The P8000 is switched ON and OFF with the ON/OFF key.
3.1.4Isolating the Mains Supply
To isolate the power supply, remove the mains plug from the wall socket.
(see Fig. 3.1)
3.1.5Potential Equalisation
The potential equalisation stud (see Fig. Fig. 3.1) at the rear of the unit can be used
to equalise the ground potential of the P8000 to that of all mains powered equipment
in the vicinity. Use the hospital or building common ground
V To prevent the possibility of leakage current when an external printer is con-
nected, always ensure that the mains lead, or the potential equalisation is attached to the P8000
Art.-no.: 9740440041 Rev.: a
Page 15
3Operation
3.1Start-up and Initial Preparation
3.1.6Inserting Printing Paper
1
Important
The device is delivered without printing paper installed. Only use original ESAOTE
printing paper. The thermo-paper is sensitive to heat, humidity and chemical vapours.
Store the paper in a cool and dry area.
1. Press the locking catch (1) to the right.
2. Open the printer door upward.
3. Insert paper and pull it down.
4. Close the cover. Be sure that the paper lies exactly between the rails.
5. Press the STOP key to transport the paper to the start position.
3.1.7LCD contrast adjustment
« Press the function key FN and the UP/DOWN arrows to adjust screen contrast.
Art.-no.: 9740440041 Rev.: a
Page 16
User GuideEntering Patient Data3.2
3.2Entering Patient Data
In this screen a new patient can be entered, or the details of a selected patient can be
modified.
« Press the patient data key.
Last Name: _
First name:
Pat. #:
Born: (dd-mm-yyyy)
Age :
Gender:
Height : cm
Weight: kg
BP: mmHg
Medications:
MENU
Operation3
Last NameEnter patients name (maximum 20 characters)
First NameEnter patients first name (maximum 20 characters)
Pat. No.The patient number is an easily identifiable short form of identifying a patient - a ma-
ximum of 20 characters can be entered.
BornEnter patient‘s date of birth dd-mm-yyyy
The patient age is calculated to the nearest year.
AgeSelf calcualted when entering date of birth.
GenderEnter the patient‘s sex M or F
HeightEnter patient‘s height 20...250 cm (10...80 inches)
WeightEnter patient‘s weight 0.5...250 kg (5...500 lbs)
BPEnter the patient‘s systolic (or diastolic) blood pressure.
MedicationUp to 23 characters can entered for medication notes
When all entries are made, press the softkey MENU to confirm the entered data.
Art.-no.: 9740440041 Rev.: a
Page 17
4Resting ECG
4.1Electrode Placement
4Resting ECG
4.1Electrode Placement
The colours shown here are according to Code 1 (European) requirements. The equivalent code 2 colours are given on paragraph 4.2.3.
Page 18
Art.-no.: 9740440041 Rev.: a
Resting ECG4
User GuideElectrode Placement4.1
A minimal resistance between skin and electrode is required to obtain the best ECG
signal and ensure the highest quality ECG recording. Therefore please note the following points:
1. Ensure that the patient is warm and relaxed.
2. Shave electrode area before cleaning.
3. Thoroughly clean the area with alcohol.
4. When applying the electrodes, ensure that a layer of gel is between the electrode
and the skin.
5. Place the C4 electrode first - in the 5th intercostal space (ICS) so that it lines up
approximately with the middle of the clavicle.
6. Then place:
– C1 in the 4th ICS parasternal right
– C2 in the 4th ICS parasternal left
– C3 between, and equidistant to, C4 and C2
– C6 on the patient‘s side and aligned with C4
– C5 between, and equidistant to, C4 and C6
The electrode resistance can be checked in the recording screen - see paragraph
4.3.1.
When making an ECG with a child it is sometimes physically difficult to place all
electrodes. When this is the case electrode C4 can be placed on the right side of the
chest.
V During the ECG recording, ensure that neither the patient nor the leading parts of
the patient connection nor the electrodes (including the neutral electrodes) come
in contact with other persons or conductive objects, even when these are earthed.
Art.-no.: 9740440041 Rev.: a
Page 19
4Resting ECG
4.2Further Lead Combinations
4.2Further Lead Combinations
4.2.1Nehb Leads
The Nehb leads are bipolar chest leads. They are of special interest for the diagnosis
of changes in the posterior ventricle wall. Three leads are arranged in the form of a
triangle, also called the “small cardiac triangle”. Nehb dorsal (D) is measured between
the electrode positions Nax and Nst; Nehb anterior (A) between Nap and Nst, and
Nehb inferior (J) between Nap and Nax.
Place the electrodes as follows:
Colour CodeElectrode identifierApplied to position
Red C1 (Nst)2nd rib at the right sternal border
Yellow C2 (Nax)directly opposite (on the back, posteriorly)
from 3 (Nap)
Green C3 (Nap)5th intercostal space medioclavicular line (car-
diac apex)
All other electrodes can be placed in their normal position The user defined lead order
must be set in the Setup menu:
MENU > SETUP > ECG SETTINGS > 4 x NEXT > NEHB (D, A, J) > on
See paragraph 5.2.5 for full details.
Spinal Column
Sternum
Page 20
Art.-no.: 9740440041 Rev.: a
User GuideFurther Lead Combinations4.2
4.2.2Electrode Positions for Additional Leads
The clips from the chest electrodes C1 through C3 have to be removed and connected to the electrodes C7 through C9 placed on the patients back in the appropriate
positions. All other electrodes can be placed in their normal position.
The user defined lead order must be set in the Setup menu:
SETUP > ECG SETTINGS > 4 x NEXT > posterior and precordials options. Set on or
off to display the additional leads.
« During data acquisition, select the lead group with the lead group keys.
See paragraph 5.2.5 for full details.
Electrode Position
Resting ECG4
Sternum
The additional leads C7 through C9 can only be recorded in manual mode.
Art.-no.: 9740440041 Rev.: a
Page 21
4Resting ECG
4.2Further Lead Combinations
4.2.3Electrodes and Neutral Electrodes Identification and
Colour Code
The electrode placements shown in this handbook are labelled with the colours according to Code 1 requirements. The equivalent Code 2 colours are given below.
C1White/redV1Brown/red
ChestC2White/yellowV2Brown/yellow
accordingC3White/greenV3Brown/green
to WilsonC4White/brownV4Brown/blue
C5White/blackV5Brown/orange
C6White/violetV6Brown/violet
ILight blue/redIOrange/red
PositionELight blue/yellowEOrange/yellow
accordingCLight blue/greenCOrange/green
to FrankALight blue/brownAOrange/brown
MLight blue/blackMOrange/black
HLight blue/violetHOrange/violet
FGreenFGreen
NeutralNBlackRLGreen
Page 22
Art.-no.: 9740440041 Rev.: a
User GuideSkin/Electrode Resistance4.3
4.3Skin/Electrode Resistance
4.3.1High Electrode Resistance Indication
If an electrode resistance is too high for a good recording, or an electrode becomes
dislodged during a recording, the electrode indication (1) flashes on the screen and an
audible beep is heard. The electrode(s) must be reapplied.
1
Resting ECG4
LEAD
TEST
Fig. 4.1Data acquisition screen
LEAD TEST [mV]
R -89C1 -98 C4-72
L -102 C2 -78 C5-121
C3 -109 C6-96
RETURN
TEST
MANUAL
PRINT
MENU
4.3.2Electrode and Patient cable Check (Lead Test)
« To check the electrode resistance and the integrity of the cable, press the LEAD
TEST key from the data acquisition screen. (see Fig 4.1.)
This gives electrode dc offset and is the voltage drop in the patient cable. It can indicate any faults in the patient cable or patient electrode. The value given is the dc voltage between the left leg electrode and all other electrodes. The measurements obtained will indicate any cable short circuits or open circuits. The measured voltage value
will depend on where the electrodes are connected. The voltage readings that can be
LEAD
MENU
expected are as follows:
• With patient connected (good connection, low resistance): ± 100mV
An offset of up to ±300mV will give an acceptable recording.
• With patient simulator connected: ±20 mV
This will depend on the patient simulator used and must be taken as a flexible measurement.
• With all electrodes shorted together: ±20 mV
• No patient cable connected: -350 to -500mV
Art.-no.: 9740440041 Rev.: a
Page 23
4Resting ECG
4.4Modes of Operation and Procedural Overview
4.4Modes of Operation and Procedural
Overview
Last Name: _
First name:
Pat. #:
Born: (dd-mm-yyyy)
Age :
Gender:
Height : cm
Weight: kg
BP: mmHg
Medications:
ECG
REST
Prepare Patient
Connect Electrodes
Switch unit on
Press the Patient
Key and enter data
MEMORY SETUP
General
Settings
Auto Format
Settings
see paragraph
5.2.2
In an emergency go straight
to data screen
LEAD
TEST
MANUAL
PRINT
MENU
Manual recordingAuto Recording
Continous 3-lead printout
until STOP pressed
12-Lead Printout (with patient data, current date, filter
settings etc., and measurement and interpretation (if
set).Recording can be saved and/or a second copy
printed if required.
View stored
Patients/
Art.-no.: 9740440041 Rev.: a
Page 24
User GuideModes of Operation and Procedural Overview4.4
4.4.1Automatic Mode
Two, user defined automatic mode formats are available. The following can be programmed freely for each of the 2 formats before recording:
• Lead Format
• Chart Speed
• With the optional interpretation program it is also possible to select the rhythm
lead(s), measurement table, average cycles with optional markings and interpretation statements for the printout.
For further information and to define the auto formats see paragraph 5.2 ECG
Settings.
« To start an automatic ECG recording in Auto Mode Format 1, press the START
key.
« To start the automatic ECG recording in Auto Mode Format 2, press the SHIFT
key followed by the START key.
After approximately 10 seconds the recording is analysed and the printout gives the
following:
Resting ECG4
LEAD
TEST
• ECG recording of all leads in either Standard or Cabrera format according to selection
• Sensitivity
• Heart Rate
• Speed
• Filter Settings
• Time and Date
• Interpretation statements (option)
• Average Cycles
• intervals
• Axis
• Sokolow Index (ECG index for hypertrophy)
• Detailed Measurement Table
The softkey options change at the end of the recording to enable you to save (1) the
recording or to obtain an extra copy (2). When a recording has been saved, it remains
stored by the P8000 until deleted, even when the unit is switched off. Accessing recordings in the memory is detailed on paragraph 4.5.
MANUAL
COPYSAVE
PRINT
MENU
2
1
Art.-no.: 9740440041 Rev.: a
When an external printer is connected, the printout is automatically directed to the external printer. When the external printer is unconnected or switched off, the P8000 automatically switches to the internal thermal printer.
Page 25
4Resting ECG
4.4Modes of Operation and Procedural Overview
4.4.2Manual Mode
Manual mode provides a direct printout of the real-time ECG with full control of parameter selection.
« To start the manual recording of a real-time ECG, press the MANUAL printout soft
key (1).
« To stop the manual recording (printout), press the STOP key (2), or the stop
softkey.
The printout provides you with the following:
LEAD
TEST
MANUAL
COPYSAVE
PRINT
MENU
1
• Three (selected) leads with lead identification.
• On the lower edge, the chart speed, user identification and the mains filter setting
(50 or 60 Hz) and the Myogram filter cutoff frequency (if filter applied) 25Hz or
35Hz.
• At the top, the heart rate as current average of 4 beats, trace sensitivity, and the
time and date
2
The lead group, the sensitivity, and the speed of the printout are changed using the
display/printout keys (see next page).
V After heavy artefacts or lead off, the indication of the heart rate may not be relia-
ble.
Manual real-time printout is not available on an external printer because data formatting protocol for inkjet (and laser) printers is too slow for real time processing. When
a continuous real-time printout of the ECG is required, it is always printed on the internal thermal printer.
Page 26
Art.-no.: 9740440041 Rev.: a
Resting ECG4
User GuideModes of Operation and Procedural Overview4.4
4.4.3Screen (and Manual Printout) Settings
The following can be freely chosen during data acquisition, for both the display and
for a manual printout, using the top line of keys of the keypad:
Lead Groupby means of the LEAD FORWARD and LEAD BACKWARD key. The following lead
groups are selectable:
Standard and Cabrera Lead Group 1-4
Lead groupType Lead group 1Lead group 2Lead group 3Lead group 4
StandardI, II, IIIaVR, aVL, aVF V1, V2, V3V4, V5, V6
CabreraaVL, I, -aVRII, aVF,IIIV1, V2, V3V4, V5, V6
Additional Lead Group 5-6
Two additionally lead groups can be viewed when manually set (on) in
SETUP > ECG SETTINGS > LEADS ( see page 37 for details).
Lead group type
Rhythm
Left Posterior
Right Precordial up to V5r
Right Precordial up to V 6r
Nehb
Lead group 5Lead group 6
II, avF, IIIV2, V4, V5
V4, V5, V6V7, V8, V9
V1, V2, V3V3r, V4r, V5r
V1, V2, V3rV4r, V5r, V6r
D, A, J
SensitivitySensitivitySelect 5, 10 or 20 mm/mV
Auto SensitivityTo reduce the possibility of overlapping traces, an auto sensitivity reduction is applied
in Auto Mode (default). This means that the unit detects very large waveform amplitudes and sets the sensitivity for the extremity and/or precordial leads to 5 mm/mV.
An ‘A‘ by the side of the sensitivity indicates that Auto sensitivity is set. To disable this
function, the AUTO SENSITIVITY key (key 3) must be pressed.
LEAD
TEST
Art.-no.: 9740440041 Rev.: a
MANUAL
COPYSAVE
PRINT
MENU
Page 27
4Resting ECG
4.4Modes of Operation and Procedural Overview
Chart SpeedSelect speed 5, 10, 25 or 50mm/s
Key 7 is a toggle key - press once and 5 is selected, press a second time and 10mm/
s is selected.
When the 25 or 50mm/s key is pressed, the same speed is set on both the screen and
the (manual) printout. When 5 or 10 mm/s is selected, this affects the manual printout
speed only.
Myogram FilterSwitch the filter ON or OFF with the FILTER key:
‘FILTER ON‘is displayed on the LCD when the filter is switched on and the cutoff frequency is shown at the bottom of the printout. That is 0.05 - 25 Hz, or 0.05 - 35 Hz.
The cutoff frequency is defined on page 35.
RecenteringPress the 1mV key to re-centre the ECG traces and/or displaying a 1mV pulse on
screen and printout.
QRS BeepTo activate / Deactivate the QRS beep, press the QRS key
Page 28
Art.-no.: 9740440041 Rev.: a
Last Name: _
First name:
Pat. #:
Born: (dd-mm-yyyy)
Age :
Gender:
Height : cm
Weight: kg
BP: mmHg
Medications:
ECG
REST
MEMORY S ETUP
Resting ECG4
User GuideMemory (option)4.5
4.5Memory (option)
The memory option allows approximately 40 recordings (depending on size and parameters specified when the recording was taken) to be stored, edited, printed, and
transmitted over the RS-232 interface. When no more recordings can be stored, the
message ‘Memory Full‘ is displayed. Old recordings must be deleted before further
recordings can be stored
Recordings can be automatically saved after a recording has been made (auto save),
or you are prompted to save a recording individually after a recording has been made.
This setting is defined in the ECG settings (see page 37).
1. Enter the memory from the initial screen.
All recordings are stored in date order.
DatePatientPat-No ECG
SELECTMENUENTER
DatePatientPat-No ECG
PRINTBACKDELETETRANSMIT
2. Highlight required recording by pressing the up/down softkeys.
To highlight all recordings press the function key .
3. When the required recording is highlighted, press the ENTER softkey.
4. Press the ENTER softkey to show the following softkeys:
Softkey options then enables you to obtain a:
• printout (PRINT)
• deletes the selected recording (DELETE)
• sends the content of the memory over the RS-232 interface to Archimed data man-
agement Software.
(TRANSMIT)
When Delete is selected, the message ‘ERASING‘ appears in the message box, during the erasing process.
Art.-no.: 9740440041 Rev.: a
The print settings are defined in Setup and are described in paragraph 4.4.3 and
5.2.2.
Page 29
4Resting ECG
4.5Memory (option)
4.5.1Transmitting the Recordings
V When non-medical devices are connected to the RS-232 interface ensure that
both units are securely connected to the same earth potential.
V When operating the unit on battery and simultaneously using non-medical devi-
ces, the RS-232 interface must be fully isolated.
V An external device must only be connected using the original interface cable as-
sembly.
The contents of the memory can be transmitted to the ArchiMed data management
program, using the RS-232 connected directly to the computer, or over the telephone
system. Sending directly is termed LINE transmission; sending over the telephone system requires a modem and this form of sending is termed MODEM.
When Transmit is selected, the message ‘TRANSMITTING‘ appears in the message
box, during the transmission.
Line TransmissionTo transmit recordings over line, proceed as follows:
1. Set Communication mode to LINE - see page 40
2. Connect the cable assembly (optional accessory, art. No. 8830649000) between
the RS-232 connector on the P8000 plus and the COM interface of the Computer.
3. Ensure that the ArchiMed SW communication program is active on the computer
(see ArchiMed SW handbook).
4. Press the TRANSMIT softkey.
Modem TransmissionTo transmit recordings over the telephone network, proceed as follows:
1. Set Communication mode to MODEM - see page 40
2. Enter Phone number and modem initialisation codes - see page 40
3. Connect the modem cable assembly (supplied with modem) between the RS-232
connector on the P8000 and the modem.
4. Ensure that the ArchiMed SW communication program is active on the remote
computer (see ArchiMed SW handbook).
5. Press the TRANSMIT softkey
The message TRANSMITTING appears while the unit is sending
If a transmission error occurs the message Tx ERROR is displayed.
« Check all settings in the ArchiMed SW communication program
– baud rate
– parity - none
– stop bit - 2
– time between blocks, records - 100ms
« Check that the transmission speed is the same in both the P8000 and the Archi-
Med SW communication program.
The transmission settings are defined in Setup and are described in paragraph 5.3.2.
Art.-no.: 9740440041 Rev.: a
Page 30
User GuideEntering the SETUP Menu5.1
5Setup
5.1Entering the SETUP Menu
To enter the setup screen press the following keys.
MENU
1. Press the softkey MENU.
Setup5
ECG
REST
1
2. Press the function key FN and the softkey SETUP.
SETUPMEMORY
Note:
The Setup text above the key appears first if the FN key is pressed.
SETUP
5.1.1Navigating in the Setup Screens
n setup screens where there are two choices, navigation to the next screen and selection of specific settings. This is as follows
Navigation with Softkeys
1. Select desired parameters with the softkeys UP/DOWN (1).
NEXTSELECTEXIT
2
1
3
2. Change setting with the softkey SELECT (2) and UP/DOWN (1).
3. Confirm the setting with the softkey SELECT (2).
4. Go to the next screen with the softkey NEXT (3)
Navigation with keypad buttons
1. Select desired parameters with the arrows keys UP/DOWN (1).
NEXTSELECTEXIT
2. Change setting with the ENTER key (3) and the arrows keys UP/DOWN (1).
3. Confirm the setting with the ENTER key (3).
4. Go to the next/previous screen with the arrows keys LEFT/RIGHT (2).
1
2
2
3
1
Art.-no.: 9740440041 Rev.: a
Page 31
5Setup
5.2ECG Settings
5.2ECG Settings
1. Press the softkey MENU.
MENU
ECG
REST
SETUP
ECG
SETTINGS
AUTOMATIC FORMAT 1
ECG Printout:short at 25 mm/S
Averages Cycles :2*6, 50bmm/s + 2 Rythm
Rhythm lead 1 :V1
Rhythm lead 1 :V1
Measurements :Off
Markings:On
Interpretation:On
SELECT
SYSTEM
SETINGS
NEXT
SETUPMEMORY
MENU
EXIT
2. Press the function key FN and the softkey SETUP.
Note:
The Setup text above the key appears first if the FN key is pressed.
3. Press the softkey ECG SETTINGS.
The following pages detail the programmable ECG parameters:
« Use the SELECT softkey (1) to select the different settings.
« Use the UP/DOWN softkeys (2) to highlight the various options.
2
NEXT
Auto. Format 1 external
Auto Format 2 internal
Automatic Format 1
internal
ECG Settings
ECG Settings
Page 32
2
1
General
Lead
Interpretation
Auto. Format 2 external
external
Filter
« Use the NEXT softkey to go to the next menus
• Automatic Format 1 and 2 internal
• Automatic Format 1 and 2 external
• Filter
• Interpretation
• Lead
• General
Art.-no.: 9740440041 Rev.: a
In units where the interpretation option is not installed, interpretation statements, cannot be displayed.
User GuideECG Settings5.2
5.2.1Automatic Format 1 and 2 Internal Printer
Two separate Auto formats can be defined for the internal printer.
Setup5
NEXT
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
Automatic Format 1
external
external
internal
General
Lead
Interpretation
Filter
ECG Settings
ECG Settings
Press the SELECT softkey to choose from the following options:
ParameterOptionsDescription
ECG Printout
No PrintoutNo printout of the ECG given at the end of an auto mode recording (the
recording can be stored in the memory and printed at a later time if requi-
red).
Short at 25 mm/sLeads are printed in short form (1 sheet) at 25 mm/s.
Short at 50 mm/sLeads are printed in short form (1 sheet) at 50 mm/s.
Long at 25 mm/sLeads are printed in long form (2 sheets) at 25 mm/s.
Long at 50 mm/sLeads are printed in long form (2 sheets) at 50 mm/s.
Average Cycles
No PrintoutNo printout of the ECG given at the end of an auto mode recording (the
recording can be stored in the memory and printed at a later time if requi-
red).
4*3, 25 mm/sLeads are printed in a 4 * 3 format at 25 mm/s
4*3, 50 mm/sLeads are printed in a 4 * 3 format at 50 mm/s
2*6, 50 mm/s + 1 RhythmLeads are averaged over the entire 10 second recording and printed in 2
groups of 6 at 50 mm/s, with the one rhythm lead at the bottom of the pa-
ge.
1*12, 50 mm/s + 2 RhythmLeads are printed in a 1 * 12 format at 25 mm/s - with 2 rhythm leads
printed.
Rhythm Lead 1
Rhythm Lead 2
Measurements
Markings
I, II, III, aVR, aVl, aVF, V1 to V6Select any lead.
I, II, III, aVR, aVl, aVF, V1 to V6Select any lead.
On/OffSelect on or off to print a detailed table of measurement results.
On/Off
Select on or off to print reference markings on the ECG average cycle
print. A vertical marker shows the beginning and end of P wave and QRS,
and the end of the T wave
Interpretation
On /OffSelect on or off to print interpretation statement
The sensitivity of the interpretation and the printing/not printing of abnormality statements can additionally be set for the interpretation. These are described in paragraph
5.2.4.
Art.-no.: 9740440041 Rev.: a
Page 33
5Setup
5.2ECG Settings
5.2.2Automatic Format 1 and 2 External Printer
Two separate Auto formats can be defined for a external printer.
NEXT
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
Automatic Format 1
external
internal
ECG Settings
ParameterOptionsDescription
ECG Printout
General
Lead
Interpretation
Filter
Press the SELECT softkey to choose from the following options:
No PrintoutNo printout of the ECG given at the end of an auto mode recording (the
recording can be stored in the memory and printed at a later time if required).
4*3 + 1 RhythmLeads are printed in a 4 * 3 format at 25 mm/s, with the selected rhythm
lead at the bottom of the page at 25 mm/s.
1*12 at 25 mm/sLeads are printed in a 1 * 12 format at 25 mm/s - no rhythm lead printed.
8*5 s + 4*10 sThe first 8 leads printed for 5 seconds and the last 4 leads printed for 10
seconds.
Short at 25 mm/sLeads are printed in short form (1 sheet) at 25 mm/s.
Short at 50 mm/sLeads are printed in short form (1 sheet) at 50 mm/s.
Long at 25 mm/sLeads are printed in long form (2 sheets) at 25 mm/s.
Long at 50 mm/sLeads are printed in long form (2 sheets) at 50 mm/s.
Average Cycles
No PrintoutNo printout of average cycles
4*3, 25 mm/s + 2 RhythmLeads are averaged over the entire 10 second recording and printed in 4
groups of 3 leads at 25 mm/s, with the two selected rhythm leads at the
bottom of the page at 25 mm/s.
4*3, 50 mm/s + 2 RhythmLeads are averaged over the entire 10 second recording and printed in 4
groups of 3 at 50 mm/s, with the two selected rhythm leads at the bottom
of the page at 25 mm/s.
2*6, 50 mm/s + 2 RhythmLeads are averaged over the entire 10 second recording and printed in 2
groups of 6 at 50 mm/s, with the two selected rhythm leads at the bottom
of the page at 25 mm/s.
Rhythm Lead 1
Rhythm Lead 2
Measurements
Markings
I, II, III, aVR, aVl, aVF, V1 to V6Select any lead.
I, II, III, aVR, aVl, aVF, V1 to V6Select any lead.
On/OffSelect on or off to print a detailed table of measurement results
On/OffSelect on or off to print reference markings on the ECG average cycle
print. A vertical marker shows the beginning and end of P wave and QRS,
and the end of the T wave
Interpretation
On /OffSelect on or off to print interpretation statement
Page 34
The sensitivity of the interpretation and the printing/not printing of abnormality statements can additionally be set for the interpretation. These are described in paragraph
5.2.4.
Full details of the interpretation option are given in the ESAOTE ECG Measurement
and Interpretation booklet (art. No. 9740440088).
Art.-no.: 9740440041 Rev.: a
User GuideECG Settings5.2
5.2.3Filters
There are five different filters which can be set individually as follows.
Setup5
NEXT
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
Automatic Format 1
external
internal
General
Lead
Interpretation
Filter
ECG Settings
ParameterOptionsDescription
Baseline filter
0.05, 0.15 or 0.3 HzThe set value is the lower limit of the frequency range and is normally set
to 0.05 Hz. The settings 0.15 and 0.30 Hz should only be used when absolutely necessary, as the possibility exists that they could affect the original ECG signal, especially the ST segments.
Myogram filter
25 or 35 Hz
The Myogram filter suppresses disturbances caused by strong muscle tremor. The filter is applied by pressing the FILTER key (or programmed on
as default when the unit is switched on).
When the Myogram filter is on, ‘FILTER ON‘ is displayed in the information
box.
The cutoff frequency is user defined at 25Hz or 35Hz. When ‘off at power
up‘ is selected, the Myogram filter is off when the unit is first switched on.
Myogram filter
Mains filter
Baseline Stabiliser
(P8000 SBS)
Smoothing Filter
P8000 SSF)
Art.-no.: 9740440041 Rev.: a
Note
An ECG recorded in auto mode is stored unfiltered. It is therefore possible
to print the stored ECG either with or without passing the myogram filter.
Filter ON is indicated on the LCD.
On at power up
Selection if filter is standard switched on or off during power up.
Off at power up
Off
50 Hz
The mains filter is an adaptive digital interference filter designed to suppress ac interference without attenuating or distorting the ECG.
60 Hz
Set the mains filter in accordance with the frequency of your local mains
supply.
Off/OnThe baseline stabiliser greatly reduces the baseline fluctuations without
affecting the ECG signal. The purpose of the stabiliser is to keep the ECG
signals on the baseline of the printout. This filter is only effective in auto
mode printout. The Baseline Stabiliser is applied to a recording (on), or not
applied to a recording (off).
Off/On
The smoothing filter is a low pass filter to suppress high frequency artefacts between the QRS complexes. When this filter is switched on, ‘SSF‘
is shown on the bottom line of the automatic printout.
Page 35
5Setup
5.2ECG Settings
5.2.4Interpretation (Only with version C)
The interpretation settings enable the user to determine whether or not certain com-
NEXT
Interpretation (option)
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
external
Automatic Format 1
internal
Filter
General
Lead
ECG Settings
ECG Settings
ParameterOptionsDescription
Sensitivity
Age Assumed to be
High or low Selecting sensitivity
<= 30 yrs
> 30 yrs
Abnormal ECG
Unconfirmed Report
Thrombolysis
Print/Not PrintNormal‘ / ‘Abnormal‘ is printed or not printed
Print/Not PrintUnconfirmed Report‘ is printed or not printed
On/Off(Only with C Software option)
ments will be added to the interpretation statements on the ECG printout. Furthermore, the patient’s age can be assumed (<30 or >30). Low or high can also be set for
interpretation sensitivity. Low sensitivity will suppress certain non-specific ECG diagnoses; this may be advisable when carrying out ECGs for screening.
Greater than 30 years, or 30 years and under
Note
The ‘Patient age assumed to be..‘ setting is only applicable
when patient data has not been entered. When a patient‘s
date of birth has been entered, this setting is ignored.
Page 36
Art.-no.: 9740440041 Rev.: a
User GuideECG Settings5.2
5.2.5Leads
Defining Lead Sequence & Printout
NEXT
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
external
Automatic Format 1
internal
General
Lead
Interpretation
Filter
ECG Settings
ECG Settings
ParameterOptionsDescription
Lead Sequence
Signals
Standard or Cabrera Select between Standard lead sequence or Cabrera.
Simultaneous
Sequential
Auto-Centering
On
Off
a
Rhythm Lead Group
a
Left Posterior (V4-V9)
a
Right Precordials (V5r)
a
Right Precordials (V6r)
a
Nehb (D, A, J)
On/OffLead group 5: II, avF, III Lead group 6: V2, V4, V5
On/OffLead group 5: V4, V5, V6 Lead group 6: V7, V8, V9
On/OffLead group 5: V1, V2, V3 Lead group 6: V3r, V4r, V5r
On/OffLead group 5: V1, V2, V3rLead group 6: V4r, V5r, V6r
On/OffLead group 5: D, A, J, (only three leads)
The required settings can be selected as follows:
Lead groupings are shown on page 27.
All ECG leads are printed in the same time segment
(in automatic mode only)
Each group is a contiguous time segment of approximately 2.5 or 5 seconds (in
automatic mode only).
All ECG traces are centred dynamically for optimal use of paper width.
Off ECG traces are set to a fixed baseline position and may possibly overlap
The lead group settings allow two extra leads to be displayed on the screen when set
to ‘On‘. The following lead groups can be displayed:
Setup5
a.The above leads can also be printed when displayed (only in manual mode). The lead groups are changed both on the screen
and on the manual printout with the lead next/previous keys.
5.2.6General (only with version m = Memory)
ParameterOptionsDescription
NEXT
Auto. Format 2 external
Auto. Format 1 external
Auto Format 2 internal
external
Automatic Format 1
internal
Art.-no.: 9740440041 Rev.: a
ECG Settings
ECG Settings
General
Lead
Interpretation
Filter
Auto-Storage
Off/Manual/
Automatic
When “Automatic”, recordings are automatically saved when an ECG is completed. When
manual is selected, the user is prompted to
save an ECG recording when completed.
Page 37
5Setup
5.3System Settings
5.3System Settings
The SYSTEM SETTINGS are entered by selecting MENU SETUP and SYSTEM
SETTINGS from the initial screen:
1. Press the softkey MENU
MENU
ECG
REST
SETUP
TEST
AND INFO
SYSTEM
SETINGS
ECG
SETTINGS
UNIT
User ID:User
Date:01-10-03 (dd-mm-yy)
Time:13:01
Ethnic:W /B
Language:English
Startup:Patient Data
Paper Mode:A4
SETUPMEMORY
MENU
EXITCOMMUNIT
2. Press the function key FN and the softkey SETUP.
Note:
The Setup text above the key appears first if the FN key is pressed.
3. Press the softkey SYSTEM SETTINGS.
4. Press the softkey UNIT.
The following pages detail system settings for the P8000:
« Use the SELECT softkey (1) to select the different settings
« Use the UP/DOWN softkeys (2) to highlight the various options.
Page 38
SELECTEXIT
122
Art.-no.: 9740440041 Rev.: a
User GuideSystem Settings5.3
5.3.1Unit
« Press softkey UNIT
TEST
AND INFO
ParameterOptionsDescription
User Identification (User ID)
Date
Time
Language
Start-up Screen
Paper
EXITCOMMUNIT
Enter user IDThe user identification is printed on all recordings. The user ID can be the
department, doctor or hospital etc. Select User ID and a blinking cursor is
present - enter up to 30 characters via the keypad.
Note
If the unit is reset to the default settings (see following), the user identification must be re-entered.
dd-mm-yy
Enter the date in the format day.month.year. When set, the ENTER key
must be pressed to confirm.
hrhr/minmin
Enter the time using the standard 24 hr notation. When set, the ENTER
key must be pressed to confirm.
Deutsch
English (Default)
Francais
Several languages are already programmed into the unit. Select the language for the screen display and for the printout. The language will also
set the units used by the system.
Svensk
American
The difference between American and English is as follows:
Italiano
Espanol
Portuges
Dutch
American Standard English
measurements in inchesmeasurements in centimetres
temperature in Fahrenheittemperature in degrees centigrade.
date order mm-dd-yydate order dd-mm-yy
Patient Data
Resting ECG
Here you can specify the first screen to be displayed when the unit is
switched on. Select between patient data screen (for entry of new patient)
or data acquisition screen (ECG).
A4
Letter
The external printer can print on A4 or letter size paper. Set according to
the paper used.
Setup5
Art.-no.: 9740440041 Rev.: a
Page 39
5Setup
5.3System Settings
5.3.2Communication
« Press softkey COMM
TEST
AND INFO
ParameterOptionsDescription
Baudrate
Mode
Phone No.
Modem Init.
EXITCOMMUNIT
9600
14400
19200
28800
38400
57600
115200
Line
Modem
T, 0417608787
P, 0417608787
ATB0L1V0Q0E0S0=0
Select a Baud rate according to the modem/computer used. Most computers can connect at 115200 Baud and the standard modem speed is 57600
Baud. If problems are experienced during transmission reduce the Baud
rate.
• line (computer connected directly to the RS-232 interface)
• modem (for transmission over the phone network)
Enter the telephone number preceded by ‘T‘ or ‘P‘ (tone or pulse).
A comma ‘,‘ gives a one second pause in dialling - this may be necessary
for example, if an outside line is required.
Enter the modem initialisation codes. Full details will be found in the user
guide for your modem. However, the modem initialisation must contain at
the minimum, the following commands with the prefix ‘AT‘.
• ‘Q0‘- modem sends response
• ‘V0‘- numerical response codes
• ‘VE0‘- no command echo
The standard modem initialisation code is: ATB0L1V0Q0E0S0=0
If in doubt about any of these settings, please contact your phone company and/or
modem supplier.
Page 40
Art.-no.: 9740440041 Rev.: a
TEST
AND INFO
Setup5
User GuideSystem Settings5.3
5.3.3Test and Information
« Press softkey TEST AND INFO to display following screen:
EXITCOMMUNIT
A code of the options installed is given after the software version. These are as follows:
« To obtain a printout press the PRINT SETUP softkey.
PRINT
SETUP
COMM
TEST
SOFTWARE
BASE
INIT.
EXIT
A printout of the defined settings will be produced and gives the following information,
depending on the installed software:
Printout for Internal and external
Print Setup MenuParameterSettings
ECG Format (1 and 2)
Internal & external
Leads
Filter
Interpretation
(only with option Interpretation)
Comm
SpeedDefault speed setting
Auto printout Long (ooo), Short (o) or Suppressed (-)
MECGAverage cycles as defined in auto ECG recording setup
(e.g. 4 * 3 (25 mm/s) + 2)
Rhythm leadsLeads selected for R1, R2 resp.
MeasurementsPrint - Enabled (+) or Suppressed (-)
MarksPrint - Enabled (+) or Suppressed (-)
InterpretationPrint - Enabled (+) or Suppressed (-)
SequenceStandard (S) or Cabrera (C)
SignalsPrintout of signals - Sequential or Simultaneous
Auto CenteringEnabled (+) or Suppressed (-)
Lead GroupRhythm, V9, V4r, V6r, DAJ, ON (+) or OFF (-) for each lead group
Baseline Filter0.05, 0.15 or 0.30 Hz
Mains Filter 50, 60 Hz or OFF (-)
Myogram Filter25 or 35 Hz, ON (+) or OFF (-)
SSB FilterSmoothing Filter Enabled (+) or Suppressed (-)
SSF Filter Baseline Stabiliser Enabled (+) or Suppressed (-)
SensitivityLow (-) or high (+) sensitivity
A30Patient age is assumed to be < 30 (-) or >30 (+)
U'Unconfirmed report' is written (+) or suppressed (-)
AbnormalNormal / Abnormal printed Enabled (+) or Suppressed (-)
ThrombolysisON (+) or OFF (-)
Baud rate115200, 57600, 38400, 28800, 14400 or 9600. This is followed by parity set-
ting (Y/N), bits and number of stop bits.
ModeLine or Modem
Page 42
Art.-no.: 9740440041 Rev.: a
PRINT
SETUP
PRINT
SETUP
COMM
TEST
COMM
TEST
SOFTWARE
SOFTWARE
User GuideSystem Settings5.3
5.3.3.2Communications Test
When this is selected, test options are given for the RS-232 communication port. Use
BASE
INIT.
EXIT
this test if the RS-232 port is suspected of malfunction. A special test plug is used to
carry out the UART test.
5.3.3.3Installing New Software Options (Upgrade)
Use the upgrade option to install any available software options (e.g. Measurement).
To install new options in the P8000, a code must be entered. This code must be obtai-
ned from ESAOTE. To install software option proceed as follows:
1. Enter the TEST and INFO screen
BASE
INIT.
EXIT
SETUP > SYSTEM SETTINGS >TEST AND INFO
2. Select SOFTWARE.
Setup5
UPGRADE
UPGRADE
UPDATE
UPDATE
3. Select UPGRADE.
EXIT
4. Enter the upgrade code.
When the correct code is entered, acceptance of the code is indicated by a series
of beeps. The option can be used immediately.
V More than 10 attempts to enter the incorrect code blocks the unit
5.3.3.4Update the Software
« Use the Update option to update the current software.
EXIT
Details to update the software is given in the P8000 Service Handbook.
Art.-no.: 9740440041 Rev.: a
Page 43
5Setup
5.3System Settings
PRINT
COMM
TEST
SOFTWARE
SETUP
5.3.3.5Default Settings
To reset the unit to the base default settings, press the BASE INIT softkey. As the unit
BASE
INIT.
EXIT
resets to the default values a message is briefly displayed on the LCD. The base settings (Defaults) are given on the following page.
Unit Defaults Table
SettingsStandardWith Interpretation
Language
Auto Format 1
Internal
Auto Format 2
external
Filter
Interpretation
Settings
Leads
General
Memory and
Communication
As setAs set
ECG: 25mm/s, short (o)ECG: 25mm/s, short (o)
Rhythm Leads V1Rhythm Leads V1, II
Interpretation: Enabled (+)
ECG: 25mm/s, Long (ooo)ECG: 25mm/s, long (ooo)
Rhythm Leads V1Rhythm Leads V1, II
MECG: none
Measurements: Suppressed (-)
Marks: Enabled (+)
Interpretation: Enabled (+)
Baseline 0.05HzBaseline 0.05Hz
Mains Filter 50Hz (60Hz)Mains Filter 50Hz (60H
Myogram off at power upMyogram off at power up
Myogram 35Hz, OFFMyogram 35Hz, OFF
SBS OFF (-)SBS OFF (-)
SSF OFF (-)SSF OFF (-)
Sensitivity low (-)
Age: <= 30 (-)
Abnormal ECG Not Print
Unconf. Report Print (+)
Thrombolysis OFF (-)
Sequence Standard (S)Sequence Standard (S)
Signals SequentialSignals Sequential
Autom. Centering ON (+)Autom. Centering ON (+)
Rhythm On (+)Rhythm On (+)
V4-9 On (+)V4-9 On (+)
V5r Off (-)V5r Off (-)
V6r Off (-)V6r Off (-)
Nehb DAJ Off (-)Nehb DAJ Off (-)
Storage mode manualStorage mode manual
Baud rate 57600 bpsBaud rate 57600 bps
Trans. mode: lineTrans. mode: line
Art.-no.: 9740440041 Rev.: a
Page 44
Care & Maintenance6
User GuideCommunication (RS-232) Test6.1
6Care & Maintenance
Maintenance work not described in this chapter, e.g. battery changes, may only be
accomplished by a qualified technician.
Self-test
Every time the unit is switched on a built-in test program is initiated. If an error is detected, the unit will not switch on and a table may be displayed giving information for
the service staff. Details of the test program is given in the P8000 Service Handbook.
6.1Communication (RS-232) Test
A built-in program to check the transmission connector. This test is entered from the
‘setup‘ menu:
SETUP > SYSTEM SETTINGS > TEST AND INFO > COMM TEST
This test uses a special test plug (not supplied) which shorts the incoming/outgoing
connectors to check transmission line and connector to ensure that the P8000 transmission circuits are functioning. Details of this test are given in the P8000 Service
Handbook.
6.212 Monthly Check
It is stipulated that a technical safety check must be performed at least every 24 months. It is strongly recommended however, that the unit undergoes a technical safety
check every 12 months.This safety check shall include the following:
• Visual inspection of the unit and cables.
• Electrical safety tests according to EN 60601-1 (1990) Clause 19
• Functional tests according to the Service Handbook.
The test results must be documented.
Art.-no.: 9740440041 Rev.: a
Page 45
6Care & Maintenance
6.3Maintenance interval for the battery
6.3Maintenance interval for the battery
Important
The battery is maintenance free during its normal life.
The battery should remain charged during storage. If the storage period exceeds
three months, recharge the battery.
• during normal operation no maintenance necessary.
• If not used every 3 months.
• replace the battery approx. every 4 years (depending upon application) if the actual
6.3.1Charging the battery
Important
A totally discharged battery requires approx. 7 hours to be 90% recharged.
It is possible to use the unit when the battery is being charged. However, when this is
the case, the charging time of the battery will be substantially extended!
1. Connect the device to the mains but do not switch it on.
2. The LED for mains supply (1) is lit.
3. Charge the battery for at least 7 hours.
running time falls substantially under 1 hour.
1
6.3.2Battery disposal
V Danger of explosion! Battery may not be burned or disposed of domestic
refuse.
V Danger of acid burns! Do not open the battery.
The battery is to be disposed of in municipally approved areas or sent back
to ESAOTE.
Page 46
Art.-no.: 9740440041 Rev.: a
Care & Maintenance6
User GuideChanging the fuse and mains voltage6.4
6.4Changing the fuse and mains voltage
V The mains voltage may only be changed by qualified personnel.
V Before the fuse and mains voltage are changed, the device must be disconnected
from the mains and remove the mains plug. See paragraph 3.1.4.
V The fuse may only be replaced by the indicated fuse type.
Changing the fuse
1. Disconnect the device from the mains and remove the mains plug. See paragraph
3.1.4.
2. Loosen the fuse inset using a screwdriver and remove it.
3. Replace existing fuses with the same type
250 VAC 2 x 200 mA (T) or 115 VAC 2 x 315 mA (T)
4. Reinsert the fuse inset.
Changing the mains voltage
1. Disconnect the device from the mains and remove the mains plug.
See paragraph 3.1.4.
2. Loosen the fuse using a screwdriver and remove it.
3. Remove the grey inset, turn it by 180° and reinsert it.
4. Check the voltage indication in the window.
5. Replace both fuses.
For:
– 250 VAC with 2 x 200 mA (T)
– 115 VAC with 2 x 315 mA (T)
6. Reinsert the fuse assembly.
Fig. 6.1Fuse inset
Art.-no.: 9740440041 Rev.: a
Page 47
6Care & Maintenance
6.5Cleaning
6.5Cleaning
6.5.1Cleaning the Casing
V Switch the unit off before cleaning and disconnect the mains. Do not, under any
circumstances, immerse the apparatus into a cleaning liquid or sterilise with hot
water, steam, or air.
The casing of the P8000 can be cleaned with a soft damp cloth on the surface only.
Where necessary a domestic non-caustic cleaner can be used for grease and finger
marks.
6.5.2Cleaning the Patient Cable
The patient cable must not be exposed to excessive mechanical stress. Whenever disconnecting the leads, hold the plugs and not the cables. Store the leads in such a
way as to prevent anyone stumbling over them or any damage being caused by the
wheels of instrument trolleys.
The cable can be wiped with soapy water. Sterilization, if required, should be done
with gas only and not with steam. To disinfect, wipe the cable with hospital standard
disinfectant.
6.5.3Cleaning the Thermal Print Head
If the printer is used a lot, a residue of ink from the grid on the paper can build up on
the print head. This can cause the print quality to deteriorate. We recommend therefore that every month the print head is cleaned with alcohol as follows:
Extend the paper tray and remove paper. The thermal printhead is found under the
paper tray.
With a tissue dampened in alcohol, gently rub the printhead to remove the ink residue.
If the printhead is badly soiled, the colour of the paper grid ink (i.e. red or green) will
show on the tissue.
Page 48
Art.-no.: 9740440041 Rev.: a
Care & Maintenance6
User GuideReplacing the Recording Paper6.6
6.6Replacing the Recording Paper
The recording paper must be replaced as soon as the end of the paper is indicated
by a red stripe on the lower edge. After the indication first appears, there are about 8
pages left. However, we recommend that the paper be replaced immediately. If no paper is left, the printing process is interrupted and a warning is given on the screen. To
replace the paper proceed as follows:
1. Press the locking catch (1) to the right. Open the printer door opens upward.
1
2. Remove any remaining paper from the paper tray.
3. Place the beginning of the paper over the black paper roller.
4. Close the cover. Be sure that the paper lies exactly between the rails.
5. Press the STOP key to transport the paper to the start position.
ESAOTE can only guarantee perfect printouts when ESAOTE original chart paper or
chart paper of the same quality is used.
6.6.1Thermal Paper Handling
The thermal paper used in the P8000 requires slightly different handling to normal paper as it can react with chemicals and to heat. However, when the following points are
remembered, the paper will give reliable results:
The following points apply to both storage, and when archiving the results.
1. Before use, keep the paper in its original cardboard cover. Do not remove the cardboard cover until the paper is to be used.
2. Store in a cool, dark and dry area.
3. Do not store near chemicals e.g. sterilisation liquids.
Art.-no.: 9740440041 Rev.: a
4. In particular do not store in a plastic cover.
5. Certain glues can react with the paper - do not attach the printout onto a mounting
sheet with glue.
Page 49
6Care & Maintenance
6.7Fault-Finding
6.7Fault-Finding
ErrorCauseRemedy
Unit does not switch on,
Blank Screen
QRS traces overlap• Wrong settings
‘Noisy’ traces• Bad electrode
No printout obtained after an
auto mode recording
Printout fades or is not clear
No printout of interpretation
statement or measurements
No key response,
LCD locked
• No mains supply, Green mains indicator off
• Contrast wrong adjusted
• Mains supply ok, but the screen is
still not lit
• Bad electrode
• Patient not relaxed
• Wrong setting
• No paper
• Wrong settings
• Old paper inserted
• Wrong inserted paper
• Dirthy print head
• Wrong setting« Check that the interpretation and measurement options
• Software hang up« Switch off, and switch on again after a few seconds.
« Check mains supply
« Check contrast. Press the function key (FN) and then the
UP/DOWN cursors keys to change the contrast.
« Press the OFF key.
Wait a few seconds and switch on again.
« If the screen is still not lit: Call your local ESAOTE repre-
sentative.
« Change sensitivity setting
« Ensure that the automatic sensitivity reduction is not
switched off.
« Reset signals to baseline - press the 1mV key
« Check electrode contact - Replace electrodes
« If traces still overlap: Call your local ESAOTE represen-
tative.
Note: Some patients have very high amplitudes and even on
the lowest sensitivity settings, the QRS traces can overlap.
« Check electrode contact
« Reapply electrodes
« Ensure that the patient is relaxed and warm
« Check all filter settings.
« Activate Myogram filter - change cutoff frequency
« Ensure mains filter is correct for mains supply
« If the trace is still ‘noisy‘: Call your local ESAOTE repre-
sentative.
« Ensure that paper is loaded.
« Check Settings - ensure that at least one item is selected
for print after an auto ECG is recorded
« If the printer still doesn‘t work: Call your local ESAOTE
representative.
« Ensure that fresh ESAOTE paper is installed.
« Note that the thermal paper used for the P8000 is heat
and light sensitive. If it is not stored in its original seal,
stored in high temperatures or is simply old, print quality
can deteriorate.
« Ensure that the paper has been installed correctly with
the paper mark at the top.
« Over a period of time, the printing ink from the grid on the
paper can form a film on the thermal print head. Clean
the thermal print head with a clean cloth as described
previously.
« If the problem persists call your local ESAOTE represen-
tative.
are enabled for the printout.
« If the unit is still not working call your local ESAOTE re-
presentative.
Art.-no.: 9740440041 Rev.: a
Page 50
User GuideFault-Finding6.7
6.7.1Accessories and Disposables
V Always use ESAOTE replacement parts and disposables, or products approved
by ESAOTE. Failure to do so may endanger life and invalidate the
guarantee.
Your local representative stocks all the disposables and accessories available for the
P8000. A full list of all ESAOTE representatives can be found on the ESAOTE website
(www.ESAOTE.com). In case of difficulty contact our head office. Our staff will be pleased to help process your order or to provide any details for all ESAOTE
products.
Care & Maintenance6
Art.-no.: 9740440041 Rev.: a
Page 51
7Technical Data
7.1System
7Technical Data
7.1System
Dimensions
Built-in monitor
Power supply
Mains Voltage
Power consumption
Battery
Battery
Capacity
Battery Life
Recharging time
Line frequency filter
Printer
Frequency range
Chart paper
Interfaces
290x 198 x 76 mm, approx. 2.6 kg
76 x 57 mm effective display area, 320 x 240 dots resolution
• 220 - 240 V (nominal), 50 / 60 Hz; 110 - 115 V (nominal), 50 / 60 Hz;
• Max. 28VA
• Operation with built-in rechargeable battery
Lead acid 12 V
• 3 hours normal use (every 10 min printout 10 pages)
• 6 hours Standby
• Under normal operating conditions, 4 years
• 90 %: approx. 7 hours, 100 %: approx. 15 hours
Distortion-free suppression of superimposed 50 or 60 Hz sinusoidal interferences by
means of adaptive digital filtering
• average complexes with optional measurement reference markings
• guidance on interpreting adult and paediatric ECG’s
25 Hz or 35 Hz, can be switched on/off
Simultaneous recording of all 9 active electrode signals (= 12 leads)
• 1000 Hz
•5 µV / 12 bit
• ≥ ±2 mV /pulse widths ≥ 0.1 ms
• 0.05 ... 150 Hz (IEC/AHA)
•dynamic ±10 mV, DC ±300 mV
• > 100 dB
• 100 MΩ
• 5000 VDC
Page 53
7Technical Data
7.3Safety Standards
7.3Safety Standards
Safety standard
EMC
Protection class
Conformity
Protection
IEC/EN 60601-1
IEC/EN 60601-2-25
IEC/EN 60601-1-2
I according to IEC/EN 60601-1 (with internal power supply)
CE according Directive 93/42/EEC IIa
This device is not designed for outdoor use (IP 20)
Page 54
Art.-no.: 9740440041 Rev.: a
User Guide
8Index
Index8
A
Abnormal ECG36
Accessories and Disposables
Age Assumed to be
Auto Mode recording
Auto Sensitivity
Auto-Centering
Automatic Format 1 and 2
Automatic Mode
Auto-Storage
Average Cycles
36
11
27
37
34
25
37
34
B
BASE INIT44
Baseline filter
Baseline Stabiliser
Battery
Battery Life
Capacity
Battery disposal
battery symbol
Baudrate
35
35
52
52
46
15
40
C
C = Interpretation41
Changes setting
Changing the fuse
Changing the mains voltage
Charging the battery
Charging time
Chart Speed
Cleaning
Colour Code
Communication
Communication (RS-232) Tes
Communications Test
Confirm the setting
Connecting AT-101
31
47
46
46
28
48
22
40
43
31
14
51
47
45
H
highlight all recordings29
I
Inserting printing paper16
Installing New Software Options
Installing New Software Options (Upgrade)
Interpretation
33, 34, 36
43
K
Keypad11
L
Languag39
LCD Screen
Lead Group
Lead Sequence
Lead Test
Leads
Left Posterior (V4-V9)
Line Transmission
13
27
37
23
37
37
30
M
M = Memory41
Mains filter
Maintenance interval for the battery
Manual Mode
Markings
Measurement
Memory
Mode
Modem Init.
Modem Transmission
Monthly Check
Myogram Filter
Myogram filter
35
46
26
33, 34
33, 34
29
40
40
304528
35
Replacing the Recording Paper
Rhythm Leads 1
Rhythm Leads 2
Right Precordials (V5r)
Right Precordials (V6r)